Job Description
Are you ready to shape the future of medicine? At Nexus BioPharm, we are accelerating life-changing therapies from bench to bedside. We are seeking a detail-oriented and visionary Senior QA Specialist to uphold our uncompromising standards of excellence.
You will join a high-performing team in the heart of the Kendall Square biotech hub, working at the intersection of innovation and regulatory precision.
Responsibilities
- Oversee end-to-end Quality Management Systems (QMS) for clinical and commercial batches.
- Lead internal and external audits to ensure global regulatory compliance (FDA/EMA/ICH).
- Manage CAPA (Corrective and Preventive Actions) investigations and provide root cause analysis.
- Review and approve batch production records, analytical data, and validation protocols.
- Collaborate with cross-functional R&D and Manufacturing teams to resolve quality deviations.
- Maintain cGMP documentation standards for all facility operations.
- Mentor junior quality associates on best practices and emerging regulatory trends.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or related Life Sciences field.
- Minimum of 5-7 years of experience in Pharmaceutical or Biopharmaceutical Quality Assurance.
- Deep understanding of 21 CFR Part 210/211 and ISO 9001 standards.
- Proven ability to manage complex investigations in a high-stakes clinical environment.
- Strong analytical, communication, and interpersonal skills.
- Professional certification (ASQ CQA/CQE) is highly preferred.
- Experience with electronic Quality Management Systems (eQMS) like TrackWise or Veeva.